Simplifying Outsourcing For Complex Formulations

Avoiding supply chain gaps and disruptions is paramount as biopharmaceutical applications work to scale toward commercial production. This is especially crucial during tech transfers, as more complex biotherapeutics such as lipid nanoparticle-based drugs (LNPs) often require more comprehensive and tightly controlled testing and manufacturing.

Because LNP formulations have structural similarities to naturally occurring biological vehicles, they are generally well tolerated by the body. As a result, LNPs are increasingly being used to deliver highly specialized therapeutics molecules, such as oligonucleotides, which themselves are seeing heightened attention in drug development, owing to their ability to tackle disease on the genetic level. Ultimately, the stability profile of a final LNP formulation is highly dependent on lipid selection and the manufacturing process. Many involve novel payloads or APIs, and interactions between various compendial raw materials commonly used are not fully understood. The supply chain requires careful and collaborative scheduling, and as such, a successful tech transfer will often rely on parallel processing transfer and development efforts at raw material suppliers.

In a recent webinar, “Considerations for Complex Formulations: How to Simplify Your Outsourcing,” experts from Ajinomoto Bio-Pharma Services explored the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.